READY-TO-USE DOCUMENTATION

Regulatory & quality system templates.

Structured, audit-ready templates built from the same framework used in client engagements — for teams that need a documented starting point rather than a blank page.

QMS Architecture

ISO 13485 / MDSAP

QMS Procedure Set — Core

Quality manual, document control, and CAPA procedures aligned to ISO 13485 clause structure.

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Internal Audit Program Kit

Audit schedule, checklist, and finding-tracking templates for inspection-readiness cycles.

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Digital & AI Alignment

ISO 42001 / SaMD

AI/SaMD Risk & Change Control Pack

Algorithm change protocol, model risk log, and governance structure templates.

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Market Authorization

EU MDR / FDA / CDSCO

GSPR Mapping Matrix

Essential requirements traceability matrix, structured for EU MDR technical documentation.

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Post-Market Surveillance Plan

PMS and PMCF planning templates with vigilance-integration structure.

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Need something built for your exact context?

Templates are a starting point. A product, classification, or market mix that needs a tailored system calls for an engagement instead of a download.